As early as December 2022, a murmur went through the medtech sector. At the EPSCO meeting (“The Employment, Social Policy, Health and Consumer Affairs Council “) shortly before Christmas, EU Commissioner Stella Kyriakides announced that the MDR would be amended in 2023. Then, in January 2023, a proposal from the Commission appeared to stagger the deadlines and relax the market. The proposal provided for only a short transitional period, so that the Parliament also agreed in its session in mid-February 2023. Now only the publication in the Official Journal is necessary so that the regulation can enter into force immediately.
However, not only the speedy decision on staggering, but also its content are pleasing – first and foremost for patients, users and notified bodies.
Like the Commission’s proposal, the final regulation primarily provides for a relief of the notified body. In contrast to the first postponement of the MDR from May 2020 to May 2021, the Commission has learned its lesson and obviously wants to avoid a focus of manufacturers and notified bodies on the extension of AIMD/MDD certificates. The focus should clearly remain on the transition to the MDR. The task packages to be fulfilled and the associated deadlines for manufacturers will also hardly change. In detail, this is to be achieved as follows.
The envisaged interventions of the Amendment Ordinance in the MDR deadlines:
The following deadlines are set out in the proposal for all manufacturers whose devices/ devices intended to substitute these devices are to be continued under the MDR:
- All manufacturers must have implemented a quality management system in accordance with the requirements of the MDR, in particular Article 10 (9), by 26 May 2024. Please note: authorities can also inspect the company with regard to the implementation of Article 10, which is not fully covered by a QM system according to DIN EN ISO 13485:2021.
- Class Ir Devices or other devices classified with the MDR from Class I to IIa or higher and thus requiring certification by a notified body for the first time may be placed on the market and put into service until 31 December 2028. Conditions are: the valid declaration of conformity according to Directive 93/42 EEC must have been signed before 26 May 2021. In addition, further “following conditions” apply, which are explained below.
- Class Im, Is, Class IIa and all Class IIb devices that are not implantable may be placed on the market until 31 December 2028 under certain conditions. In addition, this deadline also applies to except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors For more details on the “following conditions”, see below.
- Class III devices and Class IIb implantable devices (excluding except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors) may be placed on the market or put into service until 31 December 2027 under certain conditions, as they are considered to be based on established technologies. For more details on the “following conditions” see below.
However, there is no extension of the deadline for the topics of post-market surveillance, vigilance and registration: all manufacturers and economic operators must already comply with the post-market activities, the deadlines, requirements and communication channels on the topic of vigilance and the notifications of devices and the economic operators themselves in accordance with the requirements of the MDR and act accordingly.
These are the “following conditions” to be observed as long as a changeover from Directives 93/42 EEC and 90/385/EEC to (EU) 2017/745 has not yet taken place:
- Either the CE certificate to which the declaration of conformity of the device refers was issued after 25 May 2017 but before 26 May 2021, was not withdrawn from the manufacturer and is still valid on the date of entry into force of the Amendment Regulation. The date of publication in the Official Journal applies here!
- Or the CE certificate to which the declaration of conformity of the device refers was issued after 25 May 2017 but before 26 May 2021, but was no longer valid at the latest on the day before the publication of the Amendment Regulation in the Official Journal, but the manufacturer had already entered into a written agreement with a notified body referred to in the second subparagraph of Section 4.3 of Annex VII to the MDR on the conformity assessment of the device or adevice intended to substitute that device device before the expiry of the certificate. Alternatively, there may be a special authorisation or request from a national competent authority for a specific conformity assessment procedure.
- Furthermore, the devices must continue to comply with the MDD / AIMD, no significant changes must have been made to the devices and there must be no unacceptable risk to health or safety.
- Finally, the manufacturers concerned (or their European representatives) must have submitted a formal application for certification of the devicedevice or a devicedevice intended to substitute that device to a body notified under the MDR by 26 May 2024 at the latest, and there must be a written agreement between the manufacturer and the notified body by 26 September 2024.
Currently valid for manufacturers and European authorised representatives
- Contact your notified body promptly if you have not yet received an MDR certificate or have not yet started the certification process.
- Bring your QM system up to the necessary standard according to Article 10 – especially with regard to post-market surveillance, vigilance and registration
- MDR conversion projects should not be put on the back burner. Relief lies primarily with the designated bodies.
What else is worth knowing in the proposed Amendment Ordinance
- The sell-off period for AIMD and MDD devices has been removed. In concrete terms, this means that devices that have not yet been transfered to the MDR may still be made available on the market or put into service after the transfer for an unlimited period (but with a view to their life cycle). And devices that may not be continued under the MDR but were placed on the market before 26 May 2021 may also be made available or put into service for an unlimited period (but with regard to their life cycle). This is good news especially for distributors with full warehouses.
- There is also good news for manufacturers of implantable custom-made devices of Class III: if a conformity assessment procedure according to Article 52(8), second subparagraph, has been carried out without a notified body, these devices may be placed on the market or put into service until 26 May 2026. However, this also requires a formal application according to Annex VII Section 4.3 Subsection 1 to a notified body by 26 May 2024 at the latest and the signing of a written agreement according to Annex VII Section 4.3 Subsection 2 between manufacturer and notified body by 26 September 2024 at the latest.
What is still unclear after Parliament’s decision:
Even though there are very many joyful reactions to the renewed postponement or rather “equalisation” of the MDR, the Amendment Ordinance also raises further questions.
For example, it is not clear from the legal text how to deal with devices that already have an MDR certificate and also enter the re-certification phase, e.g. because they were declared compliant in 2021 and the certificate expires in 2026. “Well, that just has to be extended”, one might now think. But in which sequence compared to the old devices according to AIMD and MDD do they have to be classified?
Another question that arises is how realistic both the scenario is that the previous notified bodies “in the short term” still continue to observe the certificate issued and the manufacturers. Are the affected bodies formerly notified under MDD and AIMD still appropriately positioned, both organisationally and in terms of resources? And by when do they have to be? And how realistic is it for a body notified under the MDR to take over the surveillance of a device for which it was not previously responsible? Without some testing and/or auditing, a notified body will at least not lightly assume responsibility here.
Another fuzziness is the term “intended to substitute that device How many changes or device optimisations can a manufacturer apply for with the MDR certification application without it becoming a new, own device? Can the intended purpose be changed? Is it enough to stay in the same EMDN Code Level 4? What if there is an urgent need for optimisation? What counts as a significant change under the MDR? In these questions, manufacturers can so far only vaguely refer to the existing MDCG Guidance 2020-3. But it does not provide clarity.
And finally, it is also not clear which modules are part of the application for certification and form the content of the contracts, even if the modalities according to Annex VII 4.3 are referred to. Do manufacturers already receive a date for auditing with the contract? By when must the technical documentation be completed? How are updates to be handled, especially if there could be several years between the initial application and the review/audit? The basic idea here is that technical documentation must also be created and maintained as part of the QM system according to MDR, so manufacturers should ideally already be and remain compliant when they submit their application, even if this cannot yet be officially confirmed.
What is generally worth knowing about MDR?
The Medical Device Regulation (MDR; EU 2017/745) has been mandatory since 26 May 2021 and covers the entire life cycle of a medical device, i.e. “the placing on the market, making available on the market and putting into service in the Union of medical devices for human use and their accessories” (Article 1). Manufacturers established outside the EU must appoint a single authorised representative established in the EU. The MDR also applies to clinical investigations conducted in the Union involving these medical devices and accessories. In addition, the MDR describes how post-market surveillance should be conducted.
Classification and selection of applicable requirements
In principle, the MDR distinguishes between active and non-active medical devices, between devices without body contact, with direct or indirect contact, and even implants. Pure software applications with a medical purpose are also considered active devices – keyword: digital health applications. Medical devices are classified into classes I, IIa, IIb and III, taking into account their intended purpose and the associated risks. The classification is made according to MDR Annex VIII. In the case of implantable devices of class IIb and all class 3 devices, one also speaks of “high-risk devices”.
Irrespective of the risk class, the Essential Safety and Performance Requirements from Annex I must be selected for each device and their relevance to the medical device must be assessed. In order to present corresponding evidence of fulfilment in a structured manner, the technical documentation is prepared in accordance with Annex II and Annex III. In this evidence, criteria are fulfilled that are required from the perspective of the state of the art. Often this “state of the art” is covered by international or European standards. If a standard has been specifically aligned with the requirements of the MDR, this is formally published in the Official Journal of the European Union and is referred to as a “harmonised standard”.
In the case of missing or insufficient harmonised standards, the Commission can, according to MDR Article 9, adopt common specifications (CS), which must then be fulfilled by the manufacturers. This concerns the requirements in:
- Annex I Essential safety and performance requirements
- Annexes II and III on the contents of the technical documentation
- Annex XIV on clinical evaluation and post-market clinical follow-up
- Annex XV Requirements for clinical trials
The applied harmonised standards, common specifications as well as further legal requirements to be fulfilled, which operate according to the conformity assessment principle, shall be indicated on the related declaration of conformity of the device.
Conformity assessment and CE marking
In order to be placed on the market, medical devices require a CE marking based on a corresponding declaration of conformity. The latter results from a conformity assessment procedure by the manufacturer and, depending on the risk potential of the medical device, is carried out either by the manufacturer alone or after verification by a Notified Body. At the end, the conformity assessment procedure determines whether
- in particular, the relevant requirements of Annex 1 of the MDR have been fulfilled according to the current state of the art for a device,
- conformity may therefore be presumed (“presumption of conformity”),
- a declaration of conformity may be issued by the manufacturer, and
- the CE mark may be legally affixed.
The free movement of such devices in the Member States must not be hindered.
There are clear specifications in the MDR for the inspection by the notified body
- Annex IX regulates the conformity assessment based on a QM system and an assessment of the technical documentation,
- Annex X regulates the conformity assessment on the basis of a type examination and
- Annex XI regulates the conformity assessment based on a device conformity test.
Depending on the risk class, different annexes can be used for the review, with annex IX representing the gold standard.The clinical evaluation of certain devices in Class IIb (active devices that deliver or receive medicinal devices according to Rule 12) and Class III (implantable devices) is additionally subject to a consultation procedure (“Scrutiny Procedure”), in which, in addition to the Notified Body, a panel of experts also examines the clinical evaluation in detail and finally informs the European Commission of the result.
The certificates of the notified bodies are valid for the period stated therein, but for a maximum of 5 years; extensions are possible for 5 years at a time.
EUDAMED and subsequent obligations
Before actually placing their devices on the market, manufacturers must register them in the EUDAMED database. All European countries of destination must also be specified. Accordingly, the contractual agreements must also bind the distributors to the specifications of the MDR, so that the devices can only be delivered to the intended target countries. Because with the MDR it is clear: the labelling must be included in the respective official language of the destination country. There are only a few exceptions at national level.
Manufacturers must maintain the technical documentation, in particular the clinical evaluation, the risk management and the usability assessment, and comply with the state of the art. This is supported by the regulatory concept and the quality management system that has been established, applied and maintained. Within the framework of this system, data from downstream processes and from the market must also be collected, evaluated, incorporated into the documentation and measures taken in case of doubt. This post-market surveillance data flows into various documents and processes. Among others:
- Post-market surveillance report for class I devices
- Periodically updated safety report – “Periodic Safety Update Report” for all devices from class IIa onwards
- Summary Safety and Clinical Performance Report (SSCP) for implantable devices and class III devices other than custom-made or investigational devices
Part of this data will be made available to the public in the long term via the EUDAMED database. However, as long as the EUDAMED database does not have all modules fully set up and functioning, the above documents will first be transmitted to the own Notified Body.
You still have questions about the implementation of the MDR? You would like to know more about the regulatory requirements that are relevant for you via the Medical Devices Regulation (EU) 2017/745? Are you concerned about the development of the QM system, in particular the regulatory concept, despite the extension of the deadline? Contact us, we will be happy to advise you already now in 2023.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.
